Anti-inflammatory H1 Antihistamines Allergic Rhinitis

In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis

Sponsors

Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Source Iuliu Hatieganu University of Medicine and Pharmacy
Brief Summary

The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.

Detailed Description

Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties. We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year. Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks. The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease. Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS). A TSS<6 means a mild rhinitis, while a TSS> 6 represented a moderate severe one. The patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma. The biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha. Clinical and biological evaluation were performed before and after treatment

Overall Status Completed
Start Date 2009-02-01
Completion Date 2013-05-01
Primary Completion Date 2011-11-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
efficacy of H1 antihistamines (patients evaluation) 4 weeks
Secondary Outcome
Measure Time Frame
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion) 1.5 years
Enrollment 115
Condition
Intervention

Intervention Type: Drug

Intervention Name: Levocetirizine

Description: administration of Levocetirizine 5 mg/day for 4 weeks

Arm Group Label: Levocetirizine

Other Name: Xyzal

Intervention Type: Drug

Intervention Name: Desloratadine

Description: administration of Desloratadine 5 mg/day for 4 weeks

Arm Group Label: Desloratadine

Other Name: Aerius

Eligibility

Criteria:

Inclusion Criteria: - persistent allergic rhinitis Exclusion Criteria: - the presence of asthma or nasal polyps, - acute and chronic upper respiratory infections, - administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Verification Date

2015-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Iuliu Hatieganu University of Medicine and Pharmacy

Investigator Full Name: Stefan Cristian Vesa

Investigator Title: Assistant professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: healthy volunteers

Type: No Intervention

Description: healthy volunteers

Label: Desloratadine

Type: Active Comparator

Description: patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks

Label: Levocetirizine

Type: Active Comparator

Description: patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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